Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems

ISBN-13: 9781466502536 / Angielski / Twarda / 2017 / 406 str.

Shayne C. Gad

Opis

The concept of the perfect medicine as a molecule that goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body is especially relevant now. Much of the current costs and post-market safety concerns arise from the inability to achieve adequate concentrations and selectivity in the due course of actually delivering the active drug. Providing an integrated approach, this book presents ways of achieving the desired adequate and selective delivery using the currently available technology in three tool sets: route, regimen, and formulation.

Spis treści

Pharmacotherapy, Toxicodynamics and Regulatory Science—Divergent Objectives Nonclinical Pharmacokinetics - a primer Routes - with considerations for species specificity Delivery Systems Regimens Fundamentals of Nonclinical Formulation Excipients and Vehicles: Tolerance and toxicity Appendices

O autorze

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1971) and after active duty service in U.S. Navy, Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, Principal of Gad Consulting Services, a twenty-four year old consulting >rm with nine employees and more than 500 clients worldwide in the pharmaceutical and medical device industries. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award in 2008. Served on Council, Membership, Program, and Animals in Research committees for ACT, mul-tiple committees in SOT, and currently on the regulatory opinions commit-tee of the Society of Toxicologic Pathologists. Previously at CMIR Chemical Hygiene Fellowship, Allied Chemical, Searle, Becton Dickinson and Synergen. He has authored or edited 49 published books and more than 350 chapters, articles and abstracts in the >elds of toxicology, statistics, pharma-cology, drug and device development and safety assessment. He has more than 39 years of broad based experience in regulatory toxicology, drug and device development, statistics and risk assessment, and has speci>c exper-tise in neurotoxicology, in vitro methods, cardiovascular toxicology, inha-lation toxicology, immunotoxicology, risk assessment and genotoxicology. Grant reviewer for EPA, CAAT, NIH, and Canadian Health. He has direct involvement in the preparation of INDs (111successfullytodate),NDA,PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs.Servedas theCOOof twopharmaceuticalcompanieswhileaconsultant. CharlesB. Spainhourhas amassedapproximately forty-sevenyearsof experience in the pharmaceutical industry. For his >rst >fteen years Dr. Spainhour worked at a company known then as Smith Kline & French Laboratories and now as GlaxoSmithKline Corp., where he held positions in both the research and the development segments of the drug development process. Speci>cally, on the research side Dr. Spainhour’s activities involved the areas of phosphodiesterase inhibition, anti-diuretic hormone agonism and antagonism, dopamine agonism and antagonism, neuroleptic bio-chemistry, anti- infective mechanisms and structure-activity- relationships. On the development, side Dr. Spainhour worked in pharmacokinetics & metabolism, radiosynthesis, process chemistry and drug safety evalua-tion.Speci>careasofendeavor included H2-antagonists, leukotrienes, anti- infectives, anti-hypertensives, anti- hyperglycemic agents and anti-arrhythmics. Dr. Spainhour played a key role in the development of the >rst H2-antagonist, Cimetidine® and worked closely with Sir James Black. Dr. Spainhour has a great interest and copious amount of experience in the research and development of natural products. Dr. Spainhour has also worked as an independent consultant in the areas of safety assessment and forensic toxicology, held a position on the faculty at the veterinary school of Texas A&M University and worked as a Toxicologist in the CRO Industry previously for Pharmakon Research International, Chrysalis International, Phoenix International Life Sciences and MDS Pharma Services. Currently Dr. Spainhour serves as the Executive Vice-President and Chief Scienti>c Of>cer for Calvert Laboratories and Calvert Holdings and is the President and Chief Scienti>c Of>cer of Spainhour & Associates LLC. Dr. Spainhour holds a B.S. from Michigan State University in Biochemistry, a veterinary degree from the University of Pennsylvania and a Ph.D. from Texas A&M University (Developmental Toxicology), and is board certi>ed in forensic science, toxicology and forensic medicine.